Population Pharmacokinetic-pharmacodynamic Study of Rituximab in Children With Blood Diseases

NCT05324917 | Unknown

• 1 other identifier: YQ-KY-202101
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

To establish a population pharmacokinetic and pharmacodynamic model of rituximab in children with hemopathy. To optimize the administration of rituximab in the treatment of children based on pharmacokinetic model.

Conditions

Rituximab; Children; Blood Disease

Outcome Measures

Primary Outcomes (1)

• concentration of rituximab in plasma

  the data of plasma drug concentration and time.

  400 days

Secondary Outcomes (1)

• Incidence of adverse events

  400 days

Study Arms (2)

lymphoma patients

Patients with Burkitt's lymphoma, diffuse large B-cell lymphoma, follicular lymphoma and other mature B-lymphoma patients. Patients were randomly divided into two groups for PK blood collection. There were 12 blood sampling sites in each group.

Drug: Rituximab

Patients with B lymphoproliferative diseases

Patients with hematopoietic stem cell transplantation and Epstein-Barr virus associated b-cell lymphoproliferative diseases, b-cell lymphoproliferative changes, immune thrombocytopenia, and autoimmune hemolytic anemia. Patients were randomly divided into two groups for pharmacokinetics blood collection. There were 12 blood sampling sites in each group.

Drug: Rituximab (once a week)

Interventions

Rituximab DRUG

Chemotherapy for children with lymphoma: rituximab (375mg/m2 BSA) was added intravenously from COPADM1 regimen. once every 3 weeks to 4 weeks, combined with corresponding chemotherapy, a total of 4 times.

Also known as: Rituximab injection

lymphoma patients

Rituximab (once a week) DRUG

Rituximab (375mg/m2 BSA) was administered intravenously for lymphoproliferative diseases and EB virus-associated B lymphoproliferative diseases after hematopoietic stem cell transplantation. Once a week, a total of 4 times. ITP and AIHA patients received rituximab (100mg/m2 BSA) intravenously once a week, a total of 4 times.

Also known as: Rituximab injection (once a week)

Patients with B lymphoproliferative diseases

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Age 6 months to 18 years, histologically or cytologically proven mature B lymphoma such as Burkitt's lymphoma, diffuse large B cell lymphoma, follicular lymphoma, hematopoietic stem cell transplantation, and Epstein-Barr virus associated B lymphoproliferative disease, B cell lymphoproliferative alteration, immune thrombocytopenia. Children with autoimmune hemolytic anemia and other diseases that meet the indication of rituximab and need rituximab monotherapy or combination therapy.

You may qualify if:

• Children aged 6 months to 18 years (including 6 months and 18 years), male or female.
• Burkitt's lymphoma, diffuse large B-cell lymphoma, follicular lymphoma and other mature B-cell lymphoma confirmed by histology or cytology, hematopoietic stem cell transplantation, EB virus associated B-cell proliferative diseases, b-cell proliferative changes, immune thrombocytopenia, Autoimmune hemolytic anemia and other patients with rituximab indications should be treated with rituximab monotherapy or combination.
• Eastern Cooperative Oncology Group(ECOG) physical status score was 0-2.
• Life expectancy was at least six months.
• Women and men with reproductive potential must agree to use effective contraceptive methods during and after treatment.
• The subjects or their parents or guardians fully know and sign the informed consent, and the subjects can cooperate to complete the follow-up.

You may not qualify if:

• Patients with known hypersensitivity to rituximab and rat protein.
• Previously known active infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV), except for the following patients: Hepatitis B infection \[hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) positive\] but negative results of HBV DNA polymerase chain reaction (PCR) can be included in the group.
• A confirmed history of progressive multifocal leukoencephalopathy (PML).
• Received live vaccine within 4 weeks prior to enrollment.
• Received immunoglobulin therapy within 3 months prior to enrollment.
• Participants in the clinical trials of other drugs and taking the test drugs within 3 months.
• Any other medical condition, metabolic abnormality, physical abnormality, or laboratory abnormality of clinical significance that, in the investigator's judgment, has reason to suspect that the patient has a medical condition or condition unsuitable for rituximab or that would affect the interpretation of study results or place the patient at high risk.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: April 13, 2022
• Study Start: April 10, 2022
• Primary Completion: February 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share